Quality Manager

Quality Manager

Location: Schaffhausen (3 days onsite, 2 days homeworking)

Contract till: Dec 2024

Languages: English & German 

The Role: 

The function holder is responsible for QA oversight for selected parenteral products manufactured at the JSC Schaffhausen site. This includes quality oversight for all relevant activities in sterile fill and finish, assembly and packaging of the respective combination products (if applicable).

Main responsibilities

• On-time release of parenteral products (intermediate and finished products)

• Proactive risk mitigation

• Investigation lead for major non-conformances (deviations)

• Review and approval of non-conformances (deviations) records and change control requests

• Review and approval of GMP critical SAP master data (e. g. bill of material, manufacturing instructions etc.)

• Review and approval of work instructions and standard operating procedures

• Issue and review of Quality Agreements

• Support of projects

• Support of ‚customers‘ (production, logistics, engineering, etc.) in terms of  GMP Compliance.

• Review of Product Quality Reviews

Your Profile

• Master Degree in a technical or science discipline

• Five to ten years of experience in a GMP regulated Pharma production environment or five years of experience in a relevant quality role

• Strong background in regulatory guidelines preferred

• Knowledge in aseptic processing preferred

• Experience as team or project lead preferred

• Advanced communication skills in German and English (oral and written)

You are a team-oriented, dynamic and highly motivated person with strong communication skills. For collaboration with different departments you will need flexibility, social competence and a reasonable degree of authority. You will take decisions independently and provide advice as needed.

What’s in it for you?

As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected.

At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.

www.janssen.com

Benefits

This role offers a very competitive hourly rate.

about Johnson & Johnson

Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.

At the Leiden Site, talented and multi-skilled people are working in a high-performing culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Compliance team in Engineering, Validation and Maintenance (EVM) department we are looking for an enthusiastic and dedicated:

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”